Kornimate/medical-research-clean huggingface dataset:
investigation of benegut® on immediate gi discomfort relief caused by acute overfeeding in healthy subjects

Conditions: Healthy Volunteers

Summary: to determine the relief of gi discomfort after overfeeding with a high caloric meal.


Eligibility criteria:
inclusion criteria: * healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility. * age ≥ 25 and ≤ 70 years * bmi: 19-30 kg/m2 * overall gi discomfort after high caloric meal of at least 5 on the vas scale * male or female * written consent to participate in the study * subject is able and willing to follow the study protocol procedures * if applicable, stable intake of chronic medication of at least 3 months exclusion criteria: criteria for inclusion: * healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility. * age ≥ 25 and ≤ 70 years * bmi: 19-30 kg/m2 * overall gi discomfort after high caloric meal of at least 5 on the vas scale * male or female * written consent to participate in the study * subject is able and willing to follow the study protocol procedures * if applicable, stable intake of chronic medication of at least 3 months criteria for exclusion: * relevant history, presence of any medical disorder (e.g. cancer, severe liver disease, severe renal disease, severe cardiovascular disease) * subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or use of ppi (proton pump inhibitors) or other digestive auxiliaries potentially interfering with this study at screening * intake of antibiotics in the last 4 weeks * women suffering from distinct pms symptoms * acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeks * change of dietary habits within the 4 weeks prior to screening (for instance start of a diet high in fibers) * vegetarian or vegan nutrition style * pregnant subject or subject planning to become pregnant during the study; breast-feeding subject. * subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study. * participation in another clinical intervention study within the last 4 weeks and concurrent participation in another intervention clinical study * subject who according to the study staff's opinion is not suitable for participation in the study

Keywords: digestive health perilla frutescens
mpp narrow qrs:pilot study on multipoint pacing in patients with qrs beetwen 100 and 130 msec

Conditions: Heart Failure

Summary: the purpose of this study is to assess the impact of the multi point pacing (mpp) feature in the treatment of patients with qrs beetwen 100 and 130 msec in patients candidate to icd implant.


Eligibility criteria:
inclusion criteria: * patients with ef \< 35% on opt at least 3 months and candidate to icd * qrs duration: 100-130 ms * patients willing and able to comply with study requirements * must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form * successful quadripolar lv lead implant (only for treatment group) exclusion criteria: * myocardial infarction, unstable angina within 40 days prior the enrollment * patients with no left ventricular contractile reserve after low dose dobutamine stress echocardiography test * recent cardiac revascularization (ptca, stent or cabg) in the 4 weeks prior to enrollment or planned for the 3 months following * cerebrovascular accident (cva) or transient ischemic attack (tia) in the 3 months prior the enrollment * primary valvular disease * unable to comply with the follow up schedule * less than 18 years of age * pregnant or are planning to become pregnant during the duration of the investigation * classification of status 1 for cardiac transplantation or consideration for transplantation over the next 12 months * undergone a cardiac transplantation * life expectancy \< 12 months * patients with permanent atrial fibrillation * patients with nyha 1
a study to evaluate the safety, pharmacokinetics (pk), and pharmacodynamics (pd) of tak-079 in combination with standard background therapy in participants with moderate to severe systemic lupus erythematosus (sle)

Conditions: Systemic Lupus Erythematosus; Lupus Erythematosus, Systemic

Summary: the purpose of this study is to evaluate the safety and tolerability of tak-079 in comparison with matching placebo, administered once every 3 weeks over a 12-week dosing period in participants with active sle who are receiving stable background therapy for sle.

tak-079 is being tested in a study population with moderate to severe sle. this study will evaluate the safety and biologic activity of tak-079 or matching placebo in combination with stable sle background therapy. the study will enroll approximately 24 participants across 3 sequentially enrolling cohorts. each cohort will enroll 8 participants, where 6 participants will be assigned to tak-079 injection, and 2 participants will be assigned to placebo. participants will receive tak-079 or matching placebo in combination with principal investigator directed background therapy for sle. this multi-center trial will be conducted in the united states. participants will make multiple visits to the clinic, and will be followed up for the safety assessment for the additional 12 weeks up to week 24 after receiving their last dose of study drug. based on the clinical assessments, participants may complete or may advance to long-term safety follow up period for an additional 12-week safety monitoring period up to week 36.

Eligibility criteria:
inclusion criteria: 1. the participant been diagnosed with sle as defined by either the 2012 systemic lupus international collaborating clinics or the american college of rheumatology diagnostic criteria. 2. the participant has a systemic lupus erythematosus disease activity index 2000 (sledai-2k) score greater than or equal to (\>=) 6. 3. the participant is positive for anti-double-stranded deoxyribonucleic acid (dsdna) antibodies and/or anti-extractable nuclear antigens (ena) antibodies. exclusion criteria: 1. the participant had an opportunistic infection less than or equal to (\<=)12 weeks before initial study dosing or is currently undergoing treatment for a chronic opportunistic infection, such as tuberculosis (tb), pneumocystis pneumonia, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria. 2. the participant currently has, or recently had, an acute or chronic infection requiring one or more of the following interventions: hospitalization \<=30 days before the screening visit. - administered parenteral (iv or intramuscular) antibacterial, antiviral, antifungal, or antiparasitic agents \<=30 days before the screening visit. 3. the participant has drug-induced sle or any other rheumatologic or autoimmune disease (excluding secondary sjögren syndrome or mixed connective tissue disease).

Keywords: drug therapy
efficacy and safety of axa1665 in cirrhotic subjects with prior overt hepatic encephalopathy

Conditions: Hepatic Encephalopathy

Summary: this is a global study to compare the effects of axa1665, an orally active mixture of amino acids, compared to placebo, on cognitive and physical function, as well as the safety and tolerability of axa1665.


Eligibility criteria:
inclusion criteria: * willing to participate in the study and provide written informed consent. * male and female adults aged ≥18 years. * history of cirrhosis and at least 1 prior episode of overt hepatic encephalopathy (ohe) prior to screening. * a phes of ≤ -4 during screening. * meld score of ≤ 22 at screening. * support of a primary caregiver who is able and willing to give written informed consent. exclusion criteria: * hospitalization or serious medical condition. * presence of child's-pugh score ≥12, hepato-renal syndrome(s), refractory ascites, or spontaneous bacterial peritonitis (sbp). * history of a surgical portosystemic or a transjugular intrahepatic portosystemic shunt (tips) placement. * expectation of a liver transplant during the study. * use of marijuana or tetrahydrocannabinol (thc) within 1 week prior to screening and during the study.

Keywords: liver cirrhosis end stage liver disease sarcopenia amino acids
orbit study: a study to evaluate the safety, pharmacokinetics, and pharmacodynamics of intrathecally administered ion356 in participants with pelizaeus merzbacher disease (pmd)

Conditions: Pelizaeus-Merzbacher Disease

Summary: the primary purpose of this study is to evaluate the safety and tolerability of ion356.

this is a phase 1b, open-label multiple-ascending dose (mad) study of ion356 in approximately 24 pediatric participants with pelizaeus-merzbacher disease and genetic confirmation of proteolipid protein 1 (plp1) gene duplication. the study will have 2 parts: a 48-week multiple-ascending dose (mad) part followed by a long-term extension (lte) part of 109 weeks. eligible participants will receive doses of ion356 during the mad portion of the study and upon completion will seamlessly transition to the open-label lte to receive doses of ion356.

Eligibility criteria:
key inclusion criteria 1. participant's parent or legally accepted representative can provide informed consent, attend all scheduled study visits, provide feedback regarding the participant's symptoms, and can comply with all study requirements. 2. diagnosis of pmd with genetic confirmation of plp1 gene duplication. 3. clinical phenotype and brain imaging consistent with a diagnosis of pmd. 4. male between the ages of 2 and 17 years, inclusive, at the time of informed consent. 5. able and willing to meet all study requirements (in the opinion of the investigator), including travel to study center, procedures, measurements, and visits. exclusion criteria 1. clinically significant abnormalities in medical history, laboratory tests or physical examination. 2. unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the investigator. 3. any contraindication or unwillingness to undergo magnetic resonance imaging (mri). 4. treatment with another investigational drug, biological agent, or device within 1 month of screening, or 5 half-lives of the investigational agent, whichever is longer. 5. previous treatment with an oligonucleotide (including small interfering ribonucleic acid) within 4 months of screening if a single dose was received, or within 12 months of screening if multiple doses were received. this exclusion does not apply to vaccines (both messenger ribonucleic acid \[mrna\] and viral vector vaccines). 6. history of gene therapy or cell transplantation, or any experimental brain surgery. 7. current obstructive hydrocephalus. 8. known brain or spinal disease or previous spinal surgery that would interfere with the lumbar puncture (lp) process, csf circulation, or safety assessment. 9. hospitalization for any major medical or surgical procedure involving general anesthesia within 12 weeks prior to screening or planned during the study. 10. have any other conditions, which, in the opinion of the investigator, would make the participant unsuitable for inclusion, or could interfere with the participant participating in or completing the study.
smart bra for diagnosing breast cancer

Conditions: Breast Cancer; Medical Device

Summary: this project aims to assess the ability of a portable and connected medical device to detect breast abnormalities, for breast cancer screening. it will accelerate technological progress in the face of breast cancer.


Eligibility criteria:
inclusion criteria: * non-specific invasive carcinoma diagnosed by biopsy * x-ray images available * tumor larger than 1 cm assessed radiologically and/or by ultrasound and/or clinically * patient with a breast size compatible with the study bra size exclusion criteria: * contralateral breast cancer * inflammatory breast cancer * history of cosmetic or plastic surgery (mastopexy, prosthesis, lipomodelling) * history of breast cancer or mastectomy * presence of dermatological pathology or breast skin ulceration * hematoma post biopsy * history of thoraco-abdominal radiotherapy * known allergy to one of the materials of the device * fever (body temperature \> 37.8°c) * pacemaker port
alk/ros1/met mutations on plasma ctdna in patients with nsclc

Conditions: Non-small Cell Lung Cancer Stage III; Non-Small-Cell Lung Cancer Metastatic; Adenocarcinoma of Lung; EGFR Wildtype

Summary: the study aims to explore the prevalence of alk/ros1/met mutations assessed with ctdna samples in egfr-wildtype nsclc


Eligibility criteria:
inclusion criteria: * histologically confirmed stage iiib/iv nsclc; * histologically confirmed adenocarcinoma; * egfr-wildtype nsclc; * provision of blood (plasma) sample for ctdna testing; * patient must be able to comply with the protocol; * provision of blood (plasma) sample for ctdna testing; exclusion criteria: * as judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease); * histologically confirmed small cell lung cancer or other metastatic tumors; * patient with no histologic or cytological diagnosis;
optimizing gastrointestinal procedure appointments

Conditions: Gastrointestinal Disease

Summary: this project will address the question: does an "enhanced" ivr-t protocol differ in effectiveness from the standard ivr-t protocol in reducing missed appointments and late cancellations for gi endoscopy? hypothesis: the enhanced ivr-t protocol will be more effective.

this study will be a randomized trial over a 6-month period (march 8 through september 7, 2019) in 3 gi endoscopy clinics (franklin, rock creek, and lone tree). all members currently receive a text reminder 7 days prior to their procedure, which rolls over to a telephone reminder if the text cannot be delivered or the member's phone is not text-enabled. members will be randomized either to receive this standard ivr-t protocol (control) or to receive an enhanced reminder (intervention) protocol. randomization: beginning in march 8, 2019, a randomization algorithm will be used in the structured query language program that manages the ivr relational database to assign each visit for a procedure at all three sites to control or intervention. since members with multiple procedures on different days during the study period could receive control or intervention for different visits, the statistical analysis will be limited to the first randomized appointment during the project period. randomization will be stratified by clinic site.

Eligibility criteria:
inclusion criteria: * members scheduled for any gi procedure (upper endoscopy, colonoscopy, or both), with or without anesthesia, at all three clinical sites (franklin, rock creek, lone tree) will be included if their procedure is scheduled ≥ 2 days prior to the procedure. the ivr-t protocol will be adapted based on the wait time between appointment scheduling and the date of the procedure. * members with all clinical indications (screening, diagnosis, or surveillance), will be included. exclusion criteria: * kpco members who request not to participate in research or not to receive ivr-t or email outreach * kpco members in the "break the glass" or "code pink" protocols. * members whose procedure is scheduled \< 2 days prior to the procedure.
comparison of diagnostic rest/stress spect results for patients with myocardial ischemia and infarction using myoview in both single and dual isotope acquisition approaches

Conditions: Coronary Artery Disease

Summary: the study is designed to determine whether a dual isotope protocol is equivalent to a single isotope in the diagnosis of myocardial ischemia and infarction using myoview spect imaging.


Eligibility criteria:
inclusion criteria: 1. the subject is 18 years old or older. 2. male subjects or non-lactating female subjects, who are either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), or for women of childbearing potential, the results of a serum or urine human chorionic gonadotropin pregnancy test, performed at screening within 24 hours before dosing (with the result known before investigational medicinal product administration) must be negative. 3. the subject is able and willing to comply with study procedures (i.e., 1 spect imaging at stress, 2 spect imagings at rest) and signed and dated informed consent is obtained. 4. the subject is suspected of or known of having cad based on the subject's clinical signs, symptoms, or examinations . 5. the subject is referred for rest/stress (exercise or pharmacological) mps-spect for known or suspected cad (as clinically required). exclusion criteria: 1. the subject was previously included in this study. 2. the subject received an imp within 30 days before or is scheduled to receive one during or in the next 30 days after imp administration. 3. the subject has known allergies to any product used in this study or its constituents, including subjects who are not able to exercise and have contraindications to adenosine (e.g., asthmatics). 4. the subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month. 5. the subject has no contraindications to any of the study procedures (e.g. physical exercise) or the involved drugs (myoview, thallium-201, adenosine or dipyridamole) such as e.g. 2nd or 3rd degree av-block, ss syndrome, bradycardia, bronchoconstrictive or bronchospastic lung disease.
reconstruction of pathological changes of the ophthalmic artery in patients with retinal artery occlusion

Conditions: Retinal Artery Occlusion

Summary: retinal artery occlusions (rao) cause deterioration in visual acuity and visual fields. in computational fluid dynamics (cfd) studies \[1\] 10% of ascending emboli caused rao, the residual 90% embolized into the cerebral arteries. as only 20% of patients with rao had a history of stroke, there is a discrepancy between cfd-studies and clinical observations. mead et al. \[2\] postulated small emboli being washed into the cerebral arteries without causing clinical symptoms of stroke, whereas similar emboli being washed into the ophthalmic artery would cause rao. there is a discrepancy between cfd-study results and clinical observations in rao patients, indicating that there could be a high number of rao-patients having had cerebral ischemies without symptoms of stroke (as postulated by mead et al.\[2\]). purpose of the present study is to evaluate hemodynamic pathological changes at the ophthalmic artery origin in patients with rao detected with an already existing cfd-model

retinal artery occlusions (rao) cause deterioration in visual acuity and visual fields. emboli from plaques of the carotid artery, aortic arch or vegetations of the cardiac valves are the main reasons for rao. in computational fluid dynamics (cfd) studies \[1\] 10% of ascending emboli caused rao, the residual 90% embolized into the cerebral arteries. as only 20% of patients with rao had a history of stroke, there is a discrepancy between cfd-studies and clinical observations. mead et al. \[2\] postulated small emboli being washed into the cerebral arteries without causing clinical symptoms of stroke, whereas similar emboli being washed into the ophthalmic artery would cause rao. hayreh et al. \[3\] reported plaques of the carotid artery to be the main reason for emboli causing rao. there is a discrepancy between cfd-study results and clinical observations in rao patients, indicating that there could be a high number of rao-patients having had cerebral ischemies without symptoms of stroke (as postulated by mead et al.\[2\]). a recently published report showed ischemic cerebral lesions in 38% of patients with rao without neurological symptoms \[4\]. the fact, that the 3-year risk of patients with rao to develop stroke is doubled \[5\], underlines further associations between rao and stroke. purpose of the present study is to evaluate hemodynamic pathological changes at the ophthalmic artery origin in patients with rao detected with an already existing cfd-model references (detailed references are provided in the reference section) : \[1\] leisser et al., \[2\] mead et al., \[3\] hayreh et al., \[4\] lee et al., \[5\] chang et al.

Eligibility criteria:
inclusion criteria: * newly diagnosed rao * older than 21 years * informed consent exclusion criteria: * women in reproductive age
retroseptal transconjunctival blepharoplasty for gir

Conditions: Eyelid Diseases

Summary: the tear trough deformity is a challenging cosmetic condition.surgical treatment and filling are good treatment options

procedure is lower eyelid transconjunctival blepharoplasty associated with stromal vascular fraction gel (svf-gel) or fat transposition

Eligibility criteria:
inclusion criteria: * tear trough deformity exclusion criteria: * eyelid diseases and previous eyelid surgery

Keywords: tear trough, blepharoplasty,orbital fat
safety and efficacy of pc945 (opelconazole) in combination with other antifungal therapy for the treatment of refractory invasive pulmonary aspergillosis (opera-t study)

Conditions: Refractory IPA

Summary: to assess the safety and efficacy of nebulized pc945 in combination with systemic antifungal therapy for the treatment of refractory ipa


Eligibility criteria:
inclusion criteria: 1. participant has proven or probable ipa according to the modified 2019 european organization for research and treatment of cancer/ mycoses study group education and research consortium (eortc/msgerc) consensus definitions or according to the 2010 international society for heart and lung transplantation (ishlt) consensus statements for the definitions of infections in cardiothoracic transplant recipients. 2. participant's ipa has failed to respond to adequate antifungal therapy. exclusion criteria: 1. participant with a known or suspected concomitant medical condition or post-surgery complication that, in the opinion of the investigator, may jeopardize adherence to the protocol requirements or impede the accurate measurement of efficacy or may be an unacceptable additional risk to the participant should he/she participate in the study. 2. participant who has previously received pc945. 3. participant with a known history of allergy, hypersensitivity, or any previous serious reaction to any component of the pc945 or placebo formulations. 4. participant who has recently received, is receiving or due to receive at any time during the study, an investigational medicinal agent that does not have any regulatory approved indications. subjects who are participating in any other trials e.g., observational, diagnostic or using medications with an approved indication may be allowed to participate after consultation with the sponsor on an individual basis

Keywords: refractory ipa invasive pulmonary aspergillosis
open-label extension study of safety and tolerability of pregabalin in pediatric patients with partial-onset seizures

Conditions: Epilepsies, Partial

Summary: the study will evaluate the long-term safety and tolerability of pregabalin in pediatric patients, age 1 month through 16 years, with partial onset seizures.


Eligibility criteria:
inclusion criteria: * partial onset seizures, incompletely controlled on 1-3 medications * at least 1 seizure per 28 days, on average * completion of study a0081074 exclusion criteria: * primary generalized seizures * progressive cns pathology * failure to tolerate pregabalin in study a0081074

Keywords: partial-onset seizures; epilepsy; pediatric; pregabalin; 1 year extension study; safety; tolerability